Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections

Funding: This research was funded by the project PTDC/SAU-SER/31678/2017, supported by the Operational Program on Competitiveness and Internationalization (POCI) in its FEDER/FNR component, POCI-01-0145-FEDER-031678, and by the Foundation for Science and Technology in its state budget component (OE).Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit–risk ratio. This retrospective study aims to characterize the ADR profile of the most consumed antibiotics in Portugal that are prescribed for upper airway infections and submitted to the EudraVigilance database. The variables were analyzed in an exploratory perspective, through absolute and relative frequencies, with emphasis on serious ADR. A total of 59,022 reports were analyzed of which 64.4% were classified as suspected serious ADR. According to serious ADR, the female sex (52.2%) and 18–64 age group (47.5%) prevail. Health professionals reported 87.8% of suspected serious ADR and European Economic Area (EEA) countries represented 50.8% of the reports. “Skin and subcutaneous tissue connections” (15.9%), “general disorders and administrations site conditions” (12%), and “gastrointestinal disorders” (9.8%) are the prevalent system organ classes. In 4.5% of the reports, patients had a fatal outcome. A periodic evaluation of the safety of the antibiotic should be performed to facilitate the development of guidelines and policies to reduce the frequency of serious ADR.publishersversionpublishe

description of the methodological approach

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A preliminary study on the psychosocial impact of COVID-19 lockdown in post-bariatric surgery women: the importance of eating behavior, health care access, and social support

This study aims to characterize the psychosocial impact of COVID-19 lockdown for post-bariatric surgery (>= 36 months) women and its association with disordered eating and psychological distress. The medium to longtime follow up is a period of increased susceptibility for poorer weight outcomes which might be triggered by the lockdown. Twenty-four participants responded to an online questionnaire and a telephone interview. About half (n = 14; 58.3%) reported perceived weight gain during the lockdown, 13 (54.1%) limited access to social support, and 12 (50%) limited access to medical care. Co-habiting with a higher number of persons during lockdown was associated with fewer difficulties in dealing with emotionally activating situations, less fear of gaining weight, less fear of losing control over eating, and less disordered eating. The global perceived psychosocial impact of lockdown was significantly correlated with difficulties in dealing with emotionally activating situations and stress symptoms. Results highlight the need to monitor post-bariatric patients, facilitate health care access, and promote social support during the lockdown period.This study was conducted at the Psychology Research Centre (CIPsi/UM) School of Psychology, University of Minho, supported by the Foundation for Science and Technology (FCT) through the Portuguese State Budget (UIDB/01662/2020), by grants to Eva Conceicao (IF/01219/2014 and POCI-01-0145-FEDER-028209), and Marta de Lourdes (SFRH/BD/146470/2019). Dr. Machado was supported, in part, by a Portuguese Foundation for Science and Technology grant (POCI-01-0145-FEDER-028145). The funding body had no role in the design, collection, analysis, and interpretation of data; the writing of the manuscript; or the decision to submit the manuscript for publication

Portuguese recommendations for pain management by pharmocotherapy in inflammatory arthritis

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Implementing a PROACTive Care Pathway to Empower and Support Survivors of Breast Cancer

International audiencePURPOSE Optimal comprehensive survivorship care is insufficiently delivered. To increase patient empowerment and maximize the uptake of multidisciplinary supportive care strategies to serve all survivorship needs, we implemented a proactive survivorship care pathway for patients with early breast cancer at the end of primary treatment phase. METHODS Pathway components included (1) a personalized survivorship care plan (SCP), (2) face-to-face survivorship education seminars and personalized consultation for supportive care referrals (Transition Day), (3) a mobile app delivering personalized education and self-management advice, and (4) decision aids for physicians focused on supportive care needs. A mixed-methods process evaluation was performed according to the Reach, Effectiveness, Adoption, Implementation and Maintenance framework including administrative data review, pathway experience survey (patient, physician, and organization), and focus group. The primary objective was patient-perceived satisfaction with the pathway (predefined progression criteria for pathway continuation ≥70%). RESULTS Over 6 months, 321 patients were eligible for the pathway and received a SCP and 98 (30%) attended the Transition Day. Among 126 patients surveyed, 77 (66.1%) responded. 70.1% received the SCP, 51.9% attended the Transition Day, and 59.7% accessed the mobile app. 96.1% of patients were very or completely satisfied with the overall pathway, whereas perceived usefulness was 64.8% for the SCP, 90% for the Transition Day, and 65.2% for the mobile app. Pathway implementation seemed to be positively experienced by physicians and the organization. CONCLUSION Patients were satisfied with a proactive survivorship care pathway, and the majority reported that its components were useful in supporting their needs. This study can inform the implementation of survivorship care pathways in other centers

Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries

© 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 licenseBackground: 80% of individuals with cancer will require a surgical procedure, yet little comparative data exist on early outcomes in low-income and middle-income countries (LMICs). We compared postoperative outcomes in breast, colorectal, and gastric cancer surgery in hospitals worldwide, focusing on the effect of disease stage and complications on postoperative mortality. Methods: This was a multicentre, international prospective cohort study of consecutive adult patients undergoing surgery for primary breast, colorectal, or gastric cancer requiring a skin incision done under general or neuraxial anaesthesia. The primary outcome was death or major complication within 30 days of surgery. Multilevel logistic regression determined relationships within three-level nested models of patients within hospitals and countries. Hospital-level infrastructure effects were explored with three-way mediation analyses. This study was registered with ClinicalTrials.gov, NCT03471494. Findings: Between April 1, 2018, and Jan 31, 2019, we enrolled 15 958 patients from 428 hospitals in 82 countries (high income 9106 patients, 31 countries; upper-middle income 2721 patients, 23 countries; or lower-middle income 4131 patients, 28 countries). Patients in LMICs presented with more advanced disease compared with patients in high-income countries. 30-day mortality was higher for gastric cancer in low-income or lower-middle-income countries (adjusted odds ratio 3·72, 95% CI 1·70–8·16) and for colorectal cancer in low-income or lower-middle-income countries (4·59, 2·39–8·80) and upper-middle-income countries (2·06, 1·11–3·83). No difference in 30-day mortality was seen in breast cancer. The proportion of patients who died after a major complication was greatest in low-income or lower-middle-income countries (6·15, 3·26–11·59) and upper-middle-income countries (3·89, 2·08–7·29). Postoperative death after complications was partly explained by patient factors (60%) and partly by hospital or country (40%). The absence of consistently available postoperative care facilities was associated with seven to 10 more deaths per 100 major complications in LMICs. Cancer stage alone explained little of the early variation in mortality or postoperative complications. Interpretation: Higher levels of mortality after cancer surgery in LMICs was not fully explained by later presentation of disease. The capacity to rescue patients from surgical complications is a tangible opportunity for meaningful intervention. Early death after cancer surgery might be reduced by policies focusing on strengthening perioperative care systems to detect and intervene in common complications. Funding: National Institute for Health Research Global Health Research Unit

Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study

© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study—a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58–5·75]; p<0·0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63·0% vs 82·7%; OR 0·35 [0·23–0·53]; p<0·0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer. Interpretation: Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised. Funding: National Institute for Health and Care Research